510(k) · Cleared
ClearedUltima Tens XL-A1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tenscare, Ltd. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on May 21, 2002 as substantially equivalent to K994266 (Fuji Dynamics Limited, 2000) after a 67-day review. Its family tree reaches back 1 generation to 2000. 5 later devices descend from it.
- Decided
- May 21, 2002
- Review
- 67 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K994266 (2000). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK994266 Fdtens 2010Fuji Dynamics Limited · 2000
- This deviceK020846 Ultima Tens XL-A1Tenscare, Ltd. · 2002
- Descendant · cites it directly · 4 of its ownK023997 Tenscare Ultima NMS/EmsTenscare, Ltd. · 2003
- Descendant · 2 generations on · 3 of its ownK050921 Easystim NMS-28Easy Med Instrument Co., Ltd. · 2005
- Descendant · 3 generations on · 2 of its ownK120054 Ultima NeoPain Management Technologies · 2012
- Descendant · 4 generations on · 1 of its ownK232441 Unipro (K-UNIPRO-US)Tenscare, Ltd. · 2024
- Descendant · 5 generations on · 0 of its ownK252236 CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC · 2025
Most influential descendants
Showing 5 of 5 · See all- K023997Tenscare Ultima NMS/EmsTenscare, Ltd. · 2003 · cites it directly4descendants
- K050921Easystim NMS-28Easy Med Instrument Co., Ltd. · 2005 · 2 generations on3descendants
- K120054Ultima NeoPain Management Technologies · 2012 · 3 generations on2descendants
- K232441Unipro (K-UNIPRO-US)Tenscare, Ltd. · 2024 · 4 generations on1descendant
- K252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC · 2025 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K994266 | Fdtens 2010 | Fuji Dynamics Limited | 2000 | — |
| 0 (this device) | K020846 | Ultima Tens XL-A1 | Tenscare, Ltd. | 2002 | — |
| +1 | K023997 | Tenscare Ultima NMS/Ems | Tenscare, Ltd. | 2003 | — |
| +2 | K050921 | Easystim NMS-28 | Easy Med Instrument Co., Ltd. | 2005 | — |
| +3 | K120054 | Ultima Neo | Pain Management Technologies | 2012 | — |
| +4 | K232441 | Unipro (K-UNIPRO-US) | Tenscare, Ltd. | 2024 | — |
| +5 | K252236 | CP Relief Wand Rx - TENS/NMES | N & C Holdings, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GZJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GZJ device
- #1 K252767 actiTENS miniscore 13.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K994266 | Fdtens 2010Summary page 1…echnological Comparison: 12t March 2002 TensCare Ultima TENS device Stimulator, Nerve, Transcutaneous, for Pain Relief - 84GZJ; 21 CFR 882.5890. Class 11 FDTENS 2010 K994266 A portable TENS device for pain relief. TENS is used for the relief and management of symptomatic intractable pain and/or as an… | 2000 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023997 | Tenscare Ultima NMS/Ems | 2003 | 4 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All GZJ devicesGZJ Stimulator, Nerve, Transcutaneous, For Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GZJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GZJ
207in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZJ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GZJ
13in 2025
MAUDE reports naming product code GZJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 13 | 223 | 4 | 4 |
| 2008 | 11 | 136 | 1 | 45 |
| 2009 | 16 | 155 | 0 | 17 |
| 2010 | 5 | 232 | 0 | 22 |
| 2011 | 5 | 168 | 1 | 22 |
| 2012 | 12 | 154 | 0 | 20 |
| 2013 | 2 | — | 0 | 10 |
| 2014 | 4 | 344 | 0 | 23 |
| 2015 | 3 | 202 | 0 | 18 |
| 2016 | 3 | 163 | 0 | 32 |
| 2017 | 3 | 113 | 0 | 58 |
| 2018 | 2 | — | 0 | 21 |
| 2019 | 3 | 156 | 0 | 7 |
| 2020 | 4 | 183 | 0 | 10 |
| 2021 | 3 | 231 | 0 | 5 |
| 2022 | 4 | 175 | 0 | 4 |
| 2023 | 1 | — | 0 | 39 |
| 2024 | 3 | 207 | 0 | 12 |
| 2025 | 1 | — | 0 | 13 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
For the symptomatic relief of chronic intractable pain
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020846 · printed Nov 5, 2026
Cite this page
510(k) Report. “K020846: Ultima Tens XL-A1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020846
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026